Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain

Part of paid clinical trials in Newport, Kentucky.

Sponsor
Ethos Research & Development
Study ID
NCT06247813
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Inflammation Support Formula — DIETARY_SUPPLEMENT
    Turmeric Extract (400mg), Bioperine (Black pepper, 10mg), Ashwagandha (500mg), and Olive Leaf Extract (250mg).
  • Nerve Health Formula — DIETARY_SUPPLEMENT
    Hydroxocobalamin (Vitamin B12, 1000mcg), Pyridoxal-5-Phosphate (Vitamin B6, 50mg), LMethylfolate (400mcg) and Trimethyl Glycine (Betaine, 750mg).
  • Redox Support Formula — DIETARY_SUPPLEMENT
    N-Acetyl-L-Cysteine (500mg), CoQ10 (250mg), Acetyl-L-Carnitine (200mg), Alpha Lipoic Acid (200mg), Benfotiamine (300mg), Selenium (250mcg), Riboflavin (50mg), Zinc (15mg) and Copper (1.8mg).

Study Details

The goal of this study is to use pain-specific urine biomarkers to evaluate how daily nutritional supplementation with biomarker guided formulas effect, quality of life and urinary biomarker scores in chronic pain patients. Assessing the effect of biomarker guided supplementation on pain specific biomarkers through changes in urinary biomarker scores may solidify the necessity for identifying deficiencies to create an individualized treatment plan for pain patients. This study aims to evaluate the effect of biomarker-guided supplementation on the three categories of urinary biomarkers using targeted ingredients specifically designed for oxidative stress, inflammation, and nerve health. This study provides subjects with one of three nutritional supplement formulas based on their specific urinary biomarker test results and assesses changes in their urinary biomarker levels and their quality of life as it relates to their pain over a 3-month period.

Key Dates

Start date
Feb 8, 2024
Status verified
Sep 2024
Primary completion
Feb 15, 2025
Completion
Jul 30, 2025

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Nerve Health
  • Experimental: Oxidative Stress
  • Experimental: Inflammation

Primary Outcome Measure

Quantitative urine biomarker levels. [ Time Frame: 1 and 3 months of supplementation. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ethos Research and DevelopmentNewportKentucky41071
Brianna Krause, MS
[email protected]
352-502-3854
Joshua Gunn, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Newport, KY

By research site
Ethos Research and Development· Newport, KY

Related Studies